MAPS Statement on FDA’s Public Release of Complete Response Letter for MDMA-assisted Therapy

San Jose, CA; September 4, 2025 — In August 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Lykos Therapeutics, declining to approve MDMA-assisted therapy for Posttraumatic Stress Disorder (PTSD). Today, the FDA made this CRL publicly available for the first time, providing transparency into the agency’s decision-making process. … Continue reading MAPS Statement on FDA’s Public Release of Complete Response Letter for MDMA-assisted Therapy